I’m Rachel Zuraw. I’m live here in San Francisco. I’m an attorney specializing in, intellectual property. Especially pharmaceutical and biotechnology. With a background in bioethics >> Great. Well, we’re very happy you’re here. we have just learned a little bit about Henrietta Lacks And what we learned in the story of Henrietta Lacks is her non consensual contribution to science >> Mm-hm >> And over the years, how her cells were used for many great medical advances And her family has ultimately, really hasn’t been compensated in any way, financially. But has recently, there have been a couple of things that have happened where the NIH has put family members on a committee to help them decide how the genome of HeLa cells is going to be used, who gets the information >> Very recently >> Yeah, very, very recently. What I wanted to talk to you first about was really Just. Actually, You know? What are the ethical issues surrounding the use of specifically, Hela cells, in the case of Henrietta’s story? >> Mm-hm >> But also the, the issue of using tissues from people, without their consent, in general >> Well, that’s a big question, you know, what are the ethical issues with this, because it has to be couched in a way in a long history of failing to see consent from people who involuntarily participated in medical research, like Henrietta Lacks. it’s one of the fascinating things that Henrietta Lacks story and HeLa cells is the ability to identify An individual who participated in research without her consent. Most of the time, these sort of looking back at people who accidentally moved research forward inadvertently, not voluntarily. That’s groups of people who were in many ways taken advantage of by the medical establishment The researchers who took the cells from Henrietta, as you’ve already covered, you know, they were attempting. There were multiple attempts to find this immortal cell line, and they were taking samples from anyone they could. She was there for therapeutic treatment when they took the cell line, and at the time the, the cells were harvested from Henrietta Lacks, there were not, the informed consent guidelines weren’t in place, requiring. Well, how in-depth should I get to informed consent? >> well give it a try. I’ll stop you >> Okay. So, the Nuremberg Trials of the Nazi physicians who participated in medical experiments. Well, quasi medical experiments in the concentration camps. The, one of the first principles to come out of the Nuremberg trials is that the voluntary consent of a human research subject is absolutely essential >> Mm-hm >> And that’s been embroidered on in United States law and ethical guidelines ever since, the informed consent. That any individual participating in research needs to be told beforehand They need to have all of the information that they are able to understand, so that they can agree or not, to participate in the research >> So, it must be fully voluntary >> It must be fully voluntary, fully informed, and fully voluntary. You can’t make a voluntary choice to participate, if you don’t have all of the information. Now you mentioned the Nuremberg trials >> Yes >> Which happened I believe in the 1940s >> Yes >> but the Henrietta Lack story happened I think in 1951 >> Mm-hm >> So was there anything extra compounding the issue with Henrietta Lack that maybe hadn’t caught up yet with informed consent in the United States? [LAUGH] informed consent in the United States in the early 1950s was still a, a good theory, y’know, everyone thought that this sounded like a great idea, but then you have an uneducated patient in the hospital, who doesn’t understand what treatment she’s receiving. Is not advocating for herself. And in the consect of the time, in the context of the time, most physicians would not have paused to think, I should explain to her why I’m taking this tissue sample and let her know what I’m going to do with it. Today, and we can discuss some other examples, that sort of behavior still goes on, but it’s recognized by the medical establishment >> Mm hm >> To be an actual intrusion and invasion of the patient’s autonomy. Of the human research subject’s autonomy >> Now, for people who are hearing about this story for the first time. it may be important for us to sort of briefly discuss the idea that, You know? To use the phrase, maybe she was a victim

of the, sort of. contemporary climate and culture that she was in, may or may not be true. I mean, I guess what I want to have you speak to is, there was nothing specifically malicious done against Henrietta Lacks >> Nothing >> It’s more along the idea that there was a right that we recognize now, that was violated at that time. that happened >> Exactly. Now that’s one of the trickiest things about the Henrietta Lacks story, I agree, is that at the time when the Hela cell line was first harvested, there was no recognized duty to tell a patient that you had taken some of their genetic or cellular material for research. The researcher who took the material wasn’t even intending to profit off of it. He may have had, he may have felt, he probably would not have realistically felt any obligation to tell her if he intended to market and profit off of the Hela cell line, which he did not. But his intentions were pure in his mind He was trying to advance the scientific cause >> Mm-hm >> And there was no recognized obligation to the participants in the study to inform them of their participation >> Right. Now, obviously things have chanced since then, and, >> Incrementally [LAUGH] >> Okay, incrementally, then >> Leaps and bounds maybe not as much as we would have liked [LAUGH] [LAUGH] Well, I want you to speak to that for a second, then I mean, did the Henrietta Lack story Change anything? If not at the time eventually? And if not that were there other cases that, you know, had a bigger impact on we will get informed concent? >> Well the Henrietta Lag stories, you know, it wasn’t known for more than 40 years. So, when the Immortal Life of Henrietta Lacks was released, when Rebecca Skloot sort of publicizing the story then I think the story has now become part of a really interesting movement towards control over personal genetic information Which I think we’re really just seeing the beginnings of, because legally, there was never a recognized right of ownership or control of your, well in the past, tissues, blood sample, etc before genetic information could be extracted and used from those samples >> Mm-hm >> But now, you know Henrietta Lacks. You mentioned that her descendents Are now sitting on a committee to authorize the use of the genetic information link from the Hela cells. Likewise, there was a really interesting decision in 2010, regarding a small Indian tribe that lives in the Grand Canyon. Who had given blood samples to a University of Arizona researcher, for it to be used in diabetes and schizophrenia research one of the members of the tribe found out several years after these blood samples were donated, that they were being used for purposes that the tribe members had not consented to >> Mm-hm >> The University of Arizona, of course, argued that this was perfectly acceptable, they had the samples, they had no right of ownership to the samples. However, the ultimate outcome of this case is that the trail was able to dictate that they would not authorize their blood samples to be used for anything other than the original intended purpose and actually all of the samples that they donated were destroyed >> Mm-hm >> So I mean these are just a couple of isolated examples, case by case situations, not really setting the precedent for how we’re going to be managing, >> Mm-hm >> Genetic information that are, that is in the hands of researchers, but, it’s indicative of the interesting movement towards people becoming aware of and taking measures to control the use of their genetic information >> Now, in that same thing, I feel like I’ve heard, and maybe you’ll correct me if, if I’m wrong, If you know, Is it true that, if I had discarded a piece of my tissue or of myself. If I have left skin cells behind. If I have left bits of me, you know, a hair follicle with the root attached somewhere and someone finds it, are they free to use that sample however they see fit, if it’s been discarded from my body? >> At this time there’d be nothing to stop them, no >> Is that a hotly debated issue? >> Discarded genetic tissue, it’s being debated. I wouldn’t call it one of the biggest issues in bioethics at the moment, but it’s certainly out there and I think it’s going to become more and more of an issue as, well I mean it’s a two-fold thing, right? As both science advances such that we can do more with a discarded hair follicle And as individuals in society, non-scientists become aware of what can be done with

a discarded hair follicle, then I think you’re going to see a lot more legislation [LAUGH] aimed at >> Sure >> Aimed at preventing those uses. I mean, we’re going to talk about GINA [UNKNOWN] genetic nondiscrimination act, which, that was sparked back in 1995, before there was a very real possibility of workplaces or insurers discriminating against people based on what could be uncovered in their genome. But science was getting there and people started to worry >> Yeah, sure, I mean, it often, it seems that we rarely get ahead of the curve on these things. But, that’s one of those things where they were. I want to ask one more question, more about the Henrietta Lacks story. You know, there are people who claim that she sorry, I should say there are people who claim that, that the, the Lacks family, Henrietta Lacks family, her descendents Henrietta Lacks is deceased >> Mm-hm >> But that her family deserves some sort of the financial benefit, that has occurred from the use of her cells, and not so much morally speaking but legally speaking. When a tissue or a sample from an individual has been taken in a way that we consider unethically or illegally today, maybe not at the time, what are the ideas surrounding financial compensation, in that sense? I mean, is there any validity to those kinds of arguments? Or is that just more of people arguing from a moral standpoint? >> That is a moral standpoint. The commercial rights to your tissue, once it has been separated from your body. Are, for better or worse, pretty much zilch. one of the first cases on the area was the Regency of the United States of California versus Moore decades ago But in that particular case More, the patient was going down to UCLA for treatment of [UNKNOWN] cell leukemia. Yeah >> Mm-hm >> His physicians said that they needed to remove his spleen for therapeutic treatments. they actually intended without disclosing it to him to isolate material from his spleen and from his blood sample to create a highly profitable cell line. And for years actually, they kept him coming down. He lived in, don’t remember if it was Washington >> Mh-hm >> I think. they kept him coming down for visits that they said were therapeutic for the treatment of his leukemia But they were actually harvesting samples for use in developing a cell line that I think was valued at about $3 million. Once he found out, he sued trying to you know, get a share of this, not irrationally one would think but the courts ruled that he had the, the doctors of course, violated some rather important duties of disclosure. Towards him, that they should have, like the guidelines of the American Medical Association, their ethical guidelines require that physicians disclose if they have any commercial interest >> Mm-hm >> [LAUGH] you said they, physicians violated some duties of care in that vein, of not disclosing their commercial interest in his materials But that he had no right to any of the profits, derived from his, cellular material. And there’s actually a line of cases on that same principal. And this is actually, a really interesting debate in intellectual property and in bioethics about whether, whether giving individuals any kind of commercial right to their bodily materials, and the products derived therefrom. A lot of opponents of doing that say that it would have a drastic chilling effect on research, that if, you know, physician researchers were always going to be beholden to the individuals who hopefully knowingly donated their material to the research >> Mm-hm. Then the physician researchers wouldn’t bother to do the research in the first place to explore commercial possibilities. I don’t know whether or not that’s true. I’d like to believe a little more in altruism than perhaps that debate [LAUGH] presupposes >> Sure >> But. Fantasy world, who knows >> Right >> Anyway, that, it’s just a really interesting debate going back and forth, about whether or not to allow this kind of commercial interest And also, whether to allow, whether to allow control

>> Mm-hm >> Over the use of tissues, and now over genetic material. There have been a number of fights about whether or not, for example, a physician who has collected a number of tissue samples while at one university can take those tissue samples with him to his next university. And you know what studies can this be used for and do you legally need a, legally, you probably don’t need a consent of the donors. Ethically, Fun question >> Yeah, that is a fun question. Well, so, that, that sort of brings us to, to a new point, then. I mean, we, we, we’ve changed in the last 5800 years. We do have these new rules of, at least informed consent. Voluntary informed consent >> Mm hm >> And there seems to be a new worry, as you mentioned a second ago. In 1995 there was a, a big concern about the power of personal genetics, and what it would be used for Why are people so worried about genetic discrimination? What is the biggest worry in people normally site and say, this is scary, we need to do something about this. This is a moral imparity. What is, what is behind that? >> Aside from the movie Gatika, which I think is behind a lot of it. It’s a very scary movie >> It is >> I don’t know if you’ve seen it lately. GINA was conceived of in the past because people, people are very concerned that opportunities will be forestalled based on a possibility of some genetic issue that could befall them later on in life. If that they are being, you know, pre-judged, pre-penalized, based on something that might not happen >> It seems very, like, antithetical to the western philosophical idea of individualism and free will >> Exactly. I mean, it’s. Alright, you can understand, you know, from a gut level why of course it’s terrifying to think like, you know, why are you, why won’t you hire me, why are you charging me all of this extra money to get health insurance just because someone in my family had a health problem that will probably never effect me? No, it seems unfair >> Unfair >> which is, you know, a very high-minded, ethical and legal concept [LAUGH] >> >> What so, GINA, or the Genetic Information Nondiscrimination Act, was passed in 1995, and what did it do? >> GINA was actually signed into law in 2008. It was a very long process. So, it, the fight to create GINA first began in 1995, you know, a bunch of the bills that eventually became GINA started circulating through the government back in 95, and probably being talked of even earlier. I’m so sorry, you’re, >> No, I was going to ask what did what did GINA do? What did it say, what was the legal meaning behind it? >> Well, GINA’s general goal is to prevent discrimination by employers with 15 or more employees, or by insurers, based on an individual’s genetic information or family medical history So they included family medical history in part because, y’know, not everyone has had their genome sequenced. But the idea is, there are a lot of, this breaks down into a lot of different provisions, of course, a lot of different individual, granual protections. That the, an insurer cannot raise premiums based on the fact that, say, my aunt had breast cancer. I may or may not carry one of the BRCA gene variants that would increase my likely risk of receiving breast cancer. I cannot be charged under GINA a higher premium for that. Likewise, your insurer or your employer cannot require that you undergo any type of genetic testing to assess your risk for developing any condition. Your, it permits of course in health, a health care provider to recommend genetic testing for various purposes. But even then, an insurer or an employer can only collect the bare minimum of information that they need to have for coverage decisions. Basically they cannot collect and store additional information regarding your genetic Make up predispositions, whatever we’re going to call it >> Are there ways around that? >> How do you mean? >> I’m just wondering you know so legally I can’t raise your premium because

you have the BRCA1 mutation, >> Mm hm >> But could I raise your premium for some other reason? I mean, do, are there any examples? Workarounds where people do end up discriminating based on these based on personal genetic information, anyhow? Or is it just, is it not even something people really even try or think about doing? >> So far, it really hasn’t been an issue. and I think it’s. I think one of the reasons is because, a lot of the early thought in, you know, some of the predecessor builds to GINA was, okay. Sure, you can’t make someone take a genetic test and discriminate against them on that basis, but you can take down their family medical history, and discriminate against them on that basis. Which, of course, you know, principles of genetic inheritance so that’s why that got folded into GINA in the first place. I’m not aware of any successful work arounds actually that anyone has tried yet. Perhaps that’s because it’s an iron clad law [LAUGH] Such a great piece of legislation >> Or more likely the challenges haven’t made it into the courts yet [LAUGH] I could go with either of those. Do you feel that concern about genetic discrimination is valid? >> Absolutely. I mean, you can all to easily imagine an employer, you know, saying, you know, let’s, let’s not say breast cancer, let’s say someone who has a you know, they’ve had their genome. they’ve had their genome coded and they show a likelihood, it shows, you know, that they will almost certainly develop Huntington’s, >> Mm-hm >> Say, and an employer who wants to make a long term investment in an employee if they have access to that information, they’re allowed to make decisions based on it. Might say, you know, we really rather have some who’ll have a longer working life with us, likewise in insurer. I need insurance Make their money based on having the maximum number of basically healthy people paying into the insurance pool which then >> Right >> Goes to pay for the less healthy people. it is in the insurer’s best interest to keep as many people who are going to develop serious conditions out of that pool as possible. So yeah, I think that’s a completely rational concern that people have that led to GINA I think it’s one of the few occasions when, as you said, they got out ahead of the possibility of experiencing this type of discrimination >> You know we discussed BRCA1-1 mutations, we talked about the biology behind it and we even mention the idea that. And Myriad was a company that patented the human gene sequences, the mutations, that cause, that are the BRCA1-2 mutation. And these patents have allowed them to develop a diagnostic acid that no one else can touch that are the three dominant BRCA1-2 mutations. And they have fought vociferously in the courts to keep those patents >> It was a long and bloody battle >> What what is the current state of gene patenting in the United States? >> So the current state of gene patenting, thanks to the decision on June 2013, I think it was June 13th, 2013. On the myriad case, is that human genetic code is not patentable However, code that is synthesized from, like if you, I cannot say, I patent that mutation you have, because I discovered it! However, if you synthesize that DNA, a thing that’s called CDNA >> Mm-hm >> That is patentable, because that is a product of human innovation So a lot of the debate over the myriad case and the patenting of genes. Has really been about the purpose of patents in the United States. And you know this whole history of intellectual property protection in the United States. Which is super fun stuff that probably doesn’t need to be done in depth in a Genetics Course but the purpose of patent code is to protect the fruits of, human innovation. Either if you have worked on something. And you have created something You are entitled to control it and profit off of that. For, you know, protected period of time. Which has changed of course, throughout patent protection

history. Which you’re entitled to exclusively profit off of that for a period of time as a reward for your labor in bringing this new thing into the world. So patenting of natural materials has actually been, there’s a pretty extensive case law that this was not something that you could do. Because you can’t just, you know, discover a mold, scoop it out and say, I patent this, I get to use this mold alone. A lot of people were arguing that genes, the discovery of genetic mutation, took so much effort and took so much ingenuity to isolate. And to interpret this information, that that made it patentable And, there actually you know, Myriads patents were not the first to be issued >> Mhmm >> Myriad was really just the worst behaved patenter [LAUGH] a of human genetic information >> They didn’t make any friends >> Exactly >> Even since the Supreme Court decision, it seems that they’re still going after people. I know that there are companies that, you know, were trying to run with the Supreme Court decision and >> Mm-hm >> Myriad is still suing them >> Yes. Yeah, there, there’s plenty of clean-up work left to be done [LAUGH] >> But yeah, over the course of this litigation, people were arguing. Instead of invalidating patents like this then having this sort of compulsory licensing system was another idea that’s you know, common to further scientific innovation by licensing your patent Licensing your discovery. And the whole problem with myriad’s holding of all these patents that led to all these lawsuits is they didn’t grant any licenses Which was putting a choke hold on research. And of course an individuals ability to access a diagnostic test to determine whether or not they had these mutations >> Now, what about other genes, so, I mean, obviously we can’t patent human genes, can we patent cat genes, can we patent tree genes, can we patent bacteria genes? Unless they are synthesized, and therefore a product of human innovation, they’re not patentable >> Now what I find fascinating, and I don’t even know if you’re aware of this or not, but CDNA >> Mm-hm >> And our students don’t know about this yet, we haven’t talked about it in the course, but CDNA is a type of DNA Created when take an MRNA, which is when we have a gene in our cell, and it’s turned on, it’s transcribed into an MRNA. We have enzymes that can we can, in a lab, add to that mix and turn that MRNA back into DNA. And the interesting thing about MRNA is it’s spliced together. It originally starts out really long, but we cut a lot of pieces of the MRNA out, and the resulting MRNA is really short, and it just has the genetic information that gets turned into the protein So when you turn an MRNA back into CDNA, you only get the relevant coding information that was used, but a gene is actually much bigger. A gene itself has tons of information, called entrons, that don’t end up in the final product. But there are genes that don’t have entrons, that are just entron-less. So the MRNA is pretty much the same length as the gene itself. And I’m really curious to know what the supreme court thinks of that, because technically the information within a CDNA of an entron-less gene is the exact same as the gene itself. So I just wonder how you know if it really is about the nature of the, of the molecule, or if it has to do more with the information in the molecule. Like is it, is it the idea that it’s synthesized? >> Hm-mm >> Or is it the idea that the particular order of the information is not natural? >> That is a really, I mean I think that will be an interesting question when it inevitably turns up in court. Because the idea at this point is that you can patent something that is synthesized. I don’t know what to tell you that if the product that you synthesized is informationally completely identical to the natural product I mean, the. Although, then, the CDNA that you’re working on would still be something that you’ve produced in the lab. The CDNA >> Absolutely >> That is, you know, being circulated to other labs to do their research on. That is a lab product. As opposed to, you know, I took a sample from Matt, and I worked on that because it’s informationally identical to the cDNA. So >> Hmm. I’ll be interested, yeah, I mean >> I’ll be interested to see how that, how that shakes out >> Yeah >> But at this time, the distinction really is in the Have you synthesized it? Have you altered this from its natural state? And it’s not really about information altering, although it’s usually about purifying and distilling >> Alright so we’re going to transition

So we’re going to speak more about, sort of, your job and, or the idea of bio-ethics in, in general >> Mm-hm >> How important do you think it is for us to better understand genetic information, but also the nexus of genetic and ethics together for our future? Do you think this is going to be a more pressing need? Do you think we’ve already figured out most of the hardest stuff? [LAUGH] And hard stuff behind us? where do you see the place of bioethics in the future of genetics and personalized medicine? >> I actually think that bioethics and especially a knowledge of genetics is increasingly important, because, you know, bio-ethics, as a concept, originated as an idea of how to protect participants in research, and consumers of healthcare. People who don’t have all of the training, and the information held by the physicians and the researchers, who are, you know, bossing them around. Standing there in white coats looking scary and saying, give me your blood, I’m going to go do great things with it. It’s important in order to, protect autonomy that people have, as we’ve talked about, informed consent. You need to have the information going into a study. But I don’t think protecting informed consent is just about giving someone a form when they’re coming into a study and saying, this is exactly what we’re going to do, this is what you’re going to experience, do you sign on the dotted line? Okay. It’s about making sure that people have the tools to understand their participation in such an area, in such a venture in the first place And that’s by insuring that people are educated about, genetics, about personalized medicine. About, the that possibilities their future and their genetic code actually hold. What that actually means for them. The level of predeterminism, or not. That this information actually implies. And, well, I’m perhaps a little bit biased in favor of the study of bioethics, because I think it is super fun and interesting and really important. But, you know science is advancing at a pretty breakneck pace, and you know we won’t always get out in front of it like with GINA, but. Someone needs to be paying attention and, you know you never want to say stand in the way of any kind of scientific advancement. I don’t think that’s at all what the study of the intersection of ethics and science is about >> Mm-hm >> But, ensuring beneficial and responsible use, I think, is critical to respecting the people who make research possible >> I want to know, how did you get interested in bioethics? What’s your background? What did you study in school? >> So my background, I came to bioethics as a philosophy major, as an undergraduate I, I began studying human rationality, mostly. And philosophical conceptions of understanding individuals as rational beings. And what your ethical duties to a rational being are. That led me into studying informed consent and medical ethics. ‘ because I found it fascinating. I mean especially how you get informed consent How you get any kind of consent from someone who isn’t rational, was formerly rational, was never rational. Fun questions >> Yeah, seriously >> and then that in tern lead me actually to becoming a lawyer. Because I realized that, law is the tool that you’re actually going to use to make sure that people that cannot advocate for themselves, are none the less protected. So >> So, understanding genetics, for you then, is Or at least the certain fundamental principles of genetics is sort of central to understanding what the very questions are >> Exactly. my knowledge of genetics. I took some courses on genetics as an undergraduate, and you know, sort tried to keep up since then. Has been important toward understanding what’s going on in the world towards isolating my own research questions and to my everyday practice as a lawyer which, you know, I don’t tangle in bioethics everyday. I don’t tangle in genetics everyday. But my background with, you know, studying science and the implications of scientific discovery has landed me working in intellectual property and technology in my law firmware. I need to be ready to learn and understand a new scientific

or technological concept based on whatever case is thrown at me that particular moment, and You know the tools of knowing genetics has helped me in a couple of cases definitely [LAUGH] >> That’s good to hear. so let’s say there’s somebody watching this interview and they’re super excited. They really like the idea of bioethics. They like genetics. And they’re interested in maybe in law and they just want to know what they could do. What advice would you give to a budding young bioethicist? What would you tell them to study? Or what would you tell them to do or where would you tell them to work? >> A budding young bioethicist. Well, I’d tell them to read philosophy. Because again, exposing my own bias. where to work? I mean, there’re a lot of essentially, even when I started studying bioethics, there weren’t a lot of jobs for a bio-ethicist. Now you see jobs for bio-ethicists at pharmaceutical companies. You know who want to know both how to do their research and how to distribute their product. How to market their product hospitals. Definitely need people. There are they need bioethics consultants, actually, who mediate between physicians and patients to help, help explain the information and the implications of it. Genetic counselors are, you know, field, I don’t know if you’ve discussed in this class, but that’s what, where a lot of bioethicists wind up is, translating this kind of, you know, probabilistic determinism. You know, translating that to people who don’t have the educational background always to understand it. And help them make their decisions based on that information >> Mm-hm. So, you know, best advice I can give to learning bioethics is just be open to figuring out what the next weird issue is going to be and learn all you can about it [LAUGH] >> That’s why bioethics is fun, right? It’s sort of a, a mix between hard-nosed practicality and science fiction. You’re paying attention to, what could go wrong? And how do we stop that? Or, you know? Aspirational fiction. What, what’s not great right now? How can we make it better? >> Great. Rachel, thank you so much for comin’ in >> Thanks for bringin’ me in